Non-narcotic analgesics including aspirin are known to be effective in relieving pain and inflammation associated with the production or presence of prostaglandins. In addition to its pain relieving or inflammation relieving properties, aspirin or acetylsalicyclic acid is also known to cause irritation and ulceration of the stomach and duodenum at the doses necessary to relieve pain and inflammation. Because of this, numerous delivery systems for aspirin have been developed that buffer or reduce the ulcerative effects of aspirin.
It is also known that aspirin has significant anti-coagulant or anti-clotting properties that can reduce the risk of heart attack or related ischemic events (i.e., as a prophylactic) or it can be used during a heart attack to reduce further damage or death. When prescribed for chronic use, the dose of aspirin that is generally recommended is far less (e.g. 50–150 mgs once per day) than the dosage that is generally necessary to relieve pain and inflammation (500–650 mgs per dose as needed). The chronic administration or use of aspirin at higher doses is not generally recommended because of the potential for ulcerative bleeding.
A variety of medications have also been developed and marketed to treat and/or prevent conditions, diseases or disorders of the gastrointestinal tract. Some of the most common medications include the antacids and the anti-ulcer drugs that are sold over the counter and through prescriptions. The most commonly prescribed medication that inhibits gastric acid secretion is the compound omeprazole and that is sold under the tradename PRILOSEC®. It is known that this compound is rapidly degraded under acidic conditions.
It has surprisingly been found that the combination of the acidic acetylsalicyclic acid (aspirin) and omeprazole in a single dosage form or delivery vehicle for oral administration is useful for the treatment and prevention of heart attacks and the reduction of potential thrombotic events. This combination may be delivered without the expected degradation of the acid labile omeprazole and can include higher doses of aspirin (greater than 150 mgs) than is normally prescribed for the treatment and/or prevention of heart attacks. The combination of aspirin and omeprazole provides sufficient anti-coagulant activity while also providing a gastric acid inhibiting effect to permit delivery of higher doses of aspirin, although low doses of aspirin along with the normally recommend dose of omeprazole (10, 20, or 40 mgs QD) may also be delivered. In addition, the present invention comprises pharmaceutical compositions comprising aspirin, omeprazole and other active ingredients including, for example, citric acid and/or antioxidant agents.